Current State of PAT Applications for a Reliable and Effective PCM Equipment Operation

PAT is an integral part of every Pharmaceutical Continuous Manufacturing (PCM) control strategy. On the other hand, PAT sensors can cause equipment and process inefficiencies due to the complex nature of those instruments. Sensor technology, data volume, sensor maintenance or the interface to the process contribute to operational complexity.Nonetheless, PAT is required to measure Critical to Quality product Attributes (CQA), on-line or at-line and is enabling Real Time Release strategies. Furthermore, PAT sensors are also used during process and predictive model development, CQA monitoring, diverting Out of Specification (OOS) material and thus are essential for Real time Release testing applications. Consequently, the selection of PAT applications is a critical step in every PCM business case assessment and during the entire engineering phase of a PCM system. This presentation will provide an overview of commonly used PAT sensor technologies and their selection criteria. Furthermore, it will revisit process design criteria for the optimal positioning of those sensors within the given process flow.The overall control strategy defines what level of PAT implementation is necessary to run a successful continuous operation. All examples will be supported by real world PAT applications in operating PCM installations. Finally, this presentation should provide confidence in available PAT technologies. Innovation will aim for new even more sophisticated sensor technologies and new analytical software tools, but today PCM drug substances and drug product applications are covered and allow lead users to achieve the expected Overall Equipment Effectiveness (OEE) and required Net Present Value (NPV).

Presented by Richard Steiner, Senior Manager Business Strategy at Pharmatech Associates, A USP Company

Richard Steiner was educated at the University of Applied Sciences in Nuernberg and the FU University of Berlin and graduated as a Mechanical Engineer (Dipl. Ing.), MBM and MBA. He worked in different management positions during his times at Leistritz. From 2009 he was heading the Leistritz business unit Pharma Extrusion. In 2012 he joined GEA and became 2019 Global Sales Director for Continuous Processing Technologies at GEA Pharma Systems. In 2023 he started to work for Pharmatech Associates (a USP company), as a Senior Manager Business Strategy PCM. He contributed papers and chapters on many international conferences and scientific textbooks. His favorite topic is the implementation of continuous processing in the pharma industry (PCM).

Followed by Uwe Kirschner, Managing Director at Sentronic GmbH

Uwe Kirschner holds a degree in Electrical Engineering from the Technical University of Dresden. Already during the last months of his degree course he founded Sentronic, where he spent his entire work life so far. Together with Matthias Lau he started to work on the development of sensors based on optical technologies. At this time Sentronic also established itself as a distributor for spectroscopic components and in 2000 the knowledge gathered on the spectroscopic components was used to start the development of process systems based on optical spectroscopy. From the beginning and still today Uwe is the head of the business unit process spectroscopy at Sentronic. In this position and with the strong focus of PAT for the pharmaceutical industry Uwe gained  knowledge and experience in many aspects, in particular in instrument development, NIR spectroscopy, PAT, chemometrics, GMP and several others

Sponsored by Sentronic

Sentronic is your partner in the optical measurement of chemical and biological values. We offer technological know-how and high-tech products combined with comprehensive services. Sentronic was founded in 1993 and its headquarters is located in the nice city of Dresden / Germany. Two business sectors are designed to provide a high degree of customer and market orientation.

The business unit Spectroscopy offers customer-specific industrial solutions with modular performance packages in the area of NIR and UV/VIS spectroscopy. As a system integrator and service provider, Sentronic concentrates on PAT solutions for the pharmaceutical, chemical and food industries.

The business sector Sensors develops optical sensors on the basis of fluorescence as well as optical thin-film effects. The sensors are developed application-specific and with a focus on series production. Our intent is smart optical sensors within everybody’s reach. With nearly 30 years of experience and skills in this field of smart optical sensors, we are also the right partner for Your OEM products.

Sentronic could also be your competent partner in the measurement of chemical and biological values. Join us for a mutually successful partnership!